UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036435 |
|---|---|
| Receipt number | R000041516 |
| Scientific Title | Accuracy Assessment of Exhaled Propofol Concentration Monitoring in Patients under General Anesthesia |
| Date of disclosure of the study information | 2019/04/07 |
| Last modified on | 2020/04/07 10:26:04 |
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Basic information
Public title
Accuracy Assessment of Exhaled Propofol Concentration Monitoring in Patients under General Anesthesia
Acronym
Assessment of Exhaled Propofol Monitor
Scientific Title
Accuracy Assessment of Exhaled Propofol Concentration Monitoring in Patients under General Anesthesia
Scientific Title:Acronym
Assessment of Exhaled Propofol Monitor
Region
| Japan |
Condition
Condition
Patient Undergoing Elective Surgery under General Anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To Assess a Propfol Monitor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ratio of exhaled propofol cocentration versus plasma propofol concentration or an index simialr to the ratio during the general anesthesia
Key secondary outcomes
1. Ratio of measured propofol cocentration versus predicted plasma propofol concentration or an index simialr to the ratio during the general anesthesia
2. pharmacokinetic model to predict plasmaconcentration using exhaled propofol concentration
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Propofol will be administered using target-controlled infusion. The target concentration is controlled between 3 to 6 mcg/ml during the induction of anesthesia, and 2 to 5 mcg/ml during maintenance of anesthesia. Hydroxyethil starch 6% 130/0.4/9 of 400 to 800 ml will be infused during anesthesia. If necessary, both propofol and hydroxyethil starch will be administered beyond the limits.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient undergoing elective surgery under general anesthesia (20 patients aged 20 to 64, and 20 patients aged 65 or older)
Key exclusion criteria
(1) Contraindication to propofol or hydroxyethil starch administration
(2) Obstructive and/or restrictive ventilatory impairment
(3) American Society of Anesthesiologists physical status 4 or larger
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Masui |
Organization
Showa University School of Medicine
Division name
Department of Anesthesiology
Zip code
142-8666
Address
Hatanodai 1-5-8, Sinagawa, Tokyo, Japan
TEL
03-3784-8575
kenichi@masuinet.com
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Masui |
Organization
Showa University School of Medicine
Division name
Department of Anesthesiology
Zip code
142-8666
Address
Hatanodai 1-5-8, Sinagawa, Tokyo, Japan
TEL
03-3784-8575
Homepage URL
kenichi@masuinet.com
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University
Address
Hatanodai 1-5-8, Sinagawa, Tokyo, Japan
Tel
03-3784-8000
m-rinri@ofc.showa-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 07 | Day |
Last modified on
| 2020 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041516
